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Document Details

Submit written comments on the collection of information by December 28, 2000.

Comments Close:

12/28/2000

Document Type:

Notice

Document Citation:

65 FR 70917

Page:

70917-70918
(2 pages)

Agency/Docket Number:

Docket No. 95N-0220

Document Number:

00-30330

Document Details

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Submit written comments on the collection of information by December 28, 2000.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Petition for Approval of Substances for Use in the Preparation of Meat and Poultry Products—21 CFR 71.1 and 171.1

Sections 409 and 721 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348 and 379e) require FDA to evaluate the safety and regulate the use of food and color additives used as ingredients in or on all foods. These sections also authorize FDA to accept petitions for approval of food and color additives. The Federal Meat Inspection Act and the Poultry Products Inspection Act (21 U.S.C. 601(m)(2) and 453(g)(2), respectively) authorize the administration of the Food Safety and Inspection Service (FSIS), U.S. Department of Agriculture to determine the suitability of the use of a substance in meat and poultry products. Regulations of the two agencies regarding petition submissions at times include conditions, formats, and terms that are not fully consistent with one another because of the different statutory mandates. Under the current process, FDA and FSIS conduct separate, sequential reviews of petitions, each agency applying its respective Start Printed Page 70918procedures to ascertain that a substance is lawful for the use intended in or on products containing meat or poultry.

When petitioning for approval for the use of substances in meat and poultry products, the applicants must provide four copies of the petition to FDA, rather than the three copies as currently specified in §§ 71.1 and 171.1 (21 CFR 71.1 and 171.1). FDA will then forward a copy of the petition or relevant portions of the petition to FSIS so that both agencies can perform the necessary reviews simultaneously, thus reducing the time it takes to authorize an ingredient for use in meat and poultry products. The petitioners are not required to submit any new information to either FDA or FSIS.

This regulation results from a coordinated effort by the two agencies to ease the paperwork burden on regulated industries through streamlining the Federal Government's food ingredient approval process for substances used in meat and poultry products.

Description of Respondents: Businesses or other for profit.

In the Federal Register of August 25, 2000 (65 FR 51758), the agency requested comments on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Increase in Reporting Hour Burden1

21 CFR Section

No. of ­Respondents

Annual ­Frequency per ­Response

Total Annual Responses

Increase in Hours per ­Response

Total Increase in Hours

71.1 and 171.1

10

1

10

2

20

1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on FDA's past experience with food and color additive petitions and on discussions with FSIS about its past experience, it will receive 10 petitions annually that request approval for use of a substance in meat and poultry products. Submission of a petition for the use of a substance in meat and poultry products is a one-time event. FDA estimates that the respondent would expend 2 hours to make a fourth photocopy of the petition, necessary for FDA to send to FSIS to conduct a simultaneous review. FDA, therefore, estimates that the total burden of data collection under §§ 71.1 and 171.1 will increase by 20 hours per year because of the requirement to submit a fourth copy of petitions when a substance is to be used in meat or poultry products.